Provide active support in the continuous improvement at of the Clinical R&D Quality Management System, identify compliance weaknesses, work with staff to identify possible root cause and develop effective corrective and preventive actions;
Act as QA representative for operational teams and support functions: Actively contribute to problem solving, give support to operational teams and support functions as regard to quality related issues;
Review and give guidance to the development of clinical SOPs owned by CR&D and Global Medical Affairs and ensure that processes described in SOPs are in compliance with applicable regulations;
Manage the CR&D training program (maintenance of training records, planning and performance of staff training, organize training sessions);
Evaluate vendor qualification (from QA point of view) to support overall vendor qualification;
Perform audits at clinical study sites and vendors supporting clinical studies to evaluate compliance with GCP and with the regulations;
Accompany and support regulatory inspections.
Your profile that will convince us:
University degree (preferably medical or biosciences);
At least 3 years’ experience in the Pharmaceutical or CRO Industry, preferably in Clinical QA or Clinical Operations;
Strong analytical, problem-solving skills with excellent written and verbal communication skills;
Strong organizational, presentation, documentation and interpersonal skills;
Team oriented & willingness to travel (travel time up to 50%).